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Bolton Medical Inc.

Last updated May 23, 2026

What Bolton Medical Inc. makes

Bolton Medical Inc. manufactures endovascular stent-graft systems designed for treating aneurysms and dissections in the descending thoracic aorta and aortoiliac region. Their portfolio includes devices specifically engineered for thoracic aortic interventions, such as the RelayPro and RelayPro NBS series, which are used in minimally invasive procedures to reinforce weakened arterial walls.

These devices fall under Class III regulatory classification in the US, indicating they are subject to stringent pre-market approval requirements. They are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with US regulatory standards. The company operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Bolton Medical Inc. manufacture?

Bolton Medical Inc. specializes in endovascular stent-graft systems. These devices are primarily used to treat aneurysms and dissections in the descending thoracic aorta and the aortoiliac region. The company’s portfolio includes systems like the RelayPro and RelayPro NBS series, which are designed for minimally invasive procedures to reinforce weakened arterial walls.

Where is Bolton Medical Inc. based?

Bolton Medical Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with US-specific medical device standards.

How are Bolton Medical Inc.’s devices classified under US regulations?

Bolton Medical Inc.’s devices fall under Class III regulatory classification in the US. This classification applies to high-risk medical devices that require stringent pre-market approval due to their potential risks and benefits, ensuring rigorous evaluation before they can be authorized for use.

Are Bolton Medical Inc.’s devices listed in any regulatory registries?

Yes, Bolton Medical Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with US regulatory standards, allowing for better tracking and monitoring of the devices throughout their lifecycle.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 847424462

Catalogue (2810)

Page 1 of 57

Device	Model / Reference	Registries	Class	Status
RelayPro NBS Thoracic Stent-Graft System	28-N4-26-210-22U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-28-250-30U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-30-090-24U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-36-210-40U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-36-150-34U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-46-250-30U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-32-130-22U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-42-150-46U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-28-250-36U	FDA UDI	Class III	Active
RelayPro NBS Thoracic Stent-Graft System	28-N4-36-210-22U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-42-250-36U	FDA UDI	Class III	Active
RelayPro NBS Thoracic Stent-Graft System	28-N4-22-230-24U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-40-190-34U	FDA UDI	Class III	Active
Relay Thoracic Stent-Graft with Plus Delivery System	28M338250382590U	FDA UDI	Class III	Unknown
Relay Thoracic Stent-Graft with Plus Delivery System	28M338190382590U	FDA UDI	Class III	Unknown
RelayPro Thoracic Stent-Graft System	28-N4-44-210-34U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-30-250-24U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-40-190-38U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-38-170-38U	FDA UDI	Class III	Active
RelayPro NBS Thoracic Stent-Graft System	28-N4-22-210-30U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-42-110-46U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-40-210-42U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-28-195-24U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-36-110-26U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-38-210-36U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-26-130-22U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-22-210-38U	FDA UDI	Class III	Active
Relay Plus Thoracic Stent-Graft System	28-M332200282390U	FDA UDI	Class III	Unknown
RelayPro Thoracic Stent-Graft System	28-M4-26-250-38U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-40-170-32U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-40-170-34U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-38-110-34U	FDA UDI	Class III	Active
TREO Abdominal Stent-Graft System	28-L2-24-120U	FDA UDI	Class III	Unknown
RelayPro Thoracic Stent-Graft System	28-N4-34-190-40U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-38-150-26U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-36-110-46U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-28-170-26U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-26-250-36U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-28-210-34U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-36-130-34U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-28-150-30U	FDA UDI	Class III	Active
Relay Plus Thoracic Stent-Graft System	28-M340195362590U	FDA UDI	Class III	Unknown
Relay Plus Thoracic Stent-Graft System	28-M336145362490U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-34-130-24U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-32-170-26U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-44-200-44U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-44-250-30U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-N4-38-210-36U	FDA UDI	Class III	Active
RelayPro NBS Thoracic Stent-Graft System	28-N4-22-230-32U	FDA UDI	Class III	Active
RelayPro Thoracic Stent-Graft System	28-M4-44-230-42U	FDA UDI	Class III	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Bolton Medical Inc. has five FDA recall records initiated between December 20, 2022, and April 22, 2026. The records include completed, open, and classified statuses. Reasons cited involve discrepancies in product dimensions—such as the product being shorter than specified—incorrect stent-graft sizes relative to labeling, and labeling updates regarding potential disconnection issues that could affect deployment. One record specifically notes an incorrect stent-graft size within the delivery system.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 22, 2026	Z-2160-2026	—	open, classified	Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Feb 22, 2024	Z-1383-2024	—	completed	The stent-graft inside the delivery system was the incorrect size.
May 3, 2023	Z-1689-2023	—	open, classified	Potential for the incorrect size stent-graft than the printed carton label.
Dec 20, 2022	Z-0998-2023	—	open, classified	The product may be shorter than packaging indicates
Dec 20, 2022	Z-0997-2023	—	open, classified	The product may be shorter than packaging indicates